University of California, San Diego
San Diego, California, 92103, United States
NCT Number: NCT00530998
This is an observational study of pain and outcomes from females undergoing transvaginal NOTES removal of their appendix or gallbladder. Female subjects who elect to have a transvaginal NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following:
* Subjects will complete a 7 day pain/temperature log after surgery * Subjects will complete a standardized sexual function questionnaire (Female Sexual Function Index) prior to surgery and 6 months after surgery * Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction
Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.
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Notify Me18 year–75 year
Female
Observational
San Diego, California, 92103, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for transvaginal appendectomy:
Exclusion criteria
for transvaginal appendectomy:
Inclusion criteria
for transvaginal cholecystectomy:
Exclusion criteria
for transvaginal cholecystectomy:
The appendix will be removed via an incision in the vagina.
The gallbladder will be removed via an incision in the vagina.
Time frame: 1 year
Time frame: 1 year
University of California, San Diego
Other
Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy
Acronym: NOTES
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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